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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032551
Receipt No. R000037126
Scientific Title The prospective study about the detection of myocardial damage after radiotherapy using cardiac magnatic resonance imaging
Date of disclosure of the study information 2018/05/11
Last modified on 2018/11/25

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Basic information
Public title The prospective study about the detection of myocardial damage after radiotherapy using cardiac magnatic resonance imaging
Acronym The prospective study about radiation-induced myocardial damage using cardiac magnatic resonance imaging
Scientific Title The prospective study about the detection of myocardial damage after radiotherapy using cardiac magnatic resonance imaging
Scientific Title:Acronym The prospective study about radiation-induced myocardial damage using cardiac magnatic resonance imaging
Region
Japan

Condition
Condition Esophageal Cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is
1. To clarify myocardial changes (fibrosis) after radiotherapy using cardiac MRI.
2. To make early detection of radiation-induced heart disease and to apply these results to the future radiation plan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Confirm late gadolinium enhancement (myocardial fibrosis) corresponding to radiation field 6 months and 1.5 years after radiotherapy and evaluate the correlations between radiation dose and myocardial fibrosis.
Key secondary outcomes Examine the relationships between the frequency of cardiac events and myocardial changes.
Evaluate the correlations between the results of other examinations such as electrocardiography and myocardial changes.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Between Janualy 2013 and June 2016, the subjects will undergo cardiac MRI before, 6 month after and 1.5 years after the completion of radiation therapy.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Cases in which there is a radical adaptation of irradiation and long-term survival could be expected.
Eastern Cooperative Oncology Group performance status, 0-1.
Normal kidney function (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m2).
There is written consent of the patient.
Key exclusion criteria Cases in which the myocardium was expected to be included in radiation field.
Other active malignancy at the start of our study.
History of mediastinal radiotherapy.
History of chemotherapy.
History of heart disease.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rei Umezawa
Organization Tohoku University Hospital
Division name Department of Radiation Oncology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7312
Email reirei513@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Rei Umezawa
Organization Tohoku University Hospital
Division name Department of Radiation Oncology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7312
Homepage URL
Email reirei513@hotmail.com

Sponsor
Institute Department of Radiation Oncology, Tohoku University, Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 11 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 11 Day
Last modified on
2018 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037126

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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